This audit is carried out exclusively by a “Notified Body” such as TÜV Süd etc. and has various focuses on incorporating improvement potential into the existing processes. For example, the error and complaint management is considered.
The auditors check whether you have designed your QM documents in accordance with the standards and whether you live up to them. This means, for example, that you have already developed a product according to the standard and are now producing it.
You can prove this by providing your technical documentation (STED). In addition, the entire organization is taken into account, such as the range of further education and training measures or the handling of incoming orders right through to complaints.
If you successfully fulfill all necessary points, you will receive the DIN EN ISO 13485.